The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.
As a Senior Specialist, Global Case Management, you will be at the forefront of Moderna’s global pharmacovigilance operations, contributing to the compliant and high-quality processing of individual case safety reports (ICSRs) sourced from both clinical trials and postmarketing settings. Based in Warsaw, you will collaborate with internal teams and vendors, manage multiple intake channels, redactions, translations, and reconcile safety data — all while ensuring accuracy and timeliness in a fast-paced environment. Your attention to detail and cross-functional coordination will support Moderna's commitment to global patient safety. This role offers a unique opportunity to interact with digital tools and potentially integrate with Generative AI innovations to enhance case processing operations.
Here’s What You’ll Do:
Your key responsibilities will be:
Conduct triage and booking-in of ICSRs from diverse clinical and postmarketing sources per applicable regulations and SOPs.
Review ICSRs received via Moderna’s intake tool, ensuring quality control of automated data and validation of duplicate assessments.
Manage the Drug Safety mailbox and Translation mailbox, ensuring prompt triage, acknowledgement, reconciliation, and documentation.
Oversee translation coordination during triage/book-in and manage outbound follow-up requests for non-U.S. regions.
Perform diligent redaction of PHI from source documents and follow-up materials.
Attach and organize case-related documentation in the Argus safety database.
Your responsibilities will also include:
Engage in reconciliation of ICSRs with business partners and internal systems.
Address invalid cases and support database deletion/merge activities.
Liaise with country specialists and global case management leads to resolve region-specific issues.
Collaborate cross-functionally to enhance redaction, reconciliation, and follow-up processes.
Provide training and mentorship to new colleagues when needed.
Support inspection readiness and contribute to continuous improvement initiatives.
Participate in presentations and ongoing pharmacovigilance discussions.
Maintain task prioritization in a dynamic workload environment, escalating when needed.
The key Moderna Mindsets you’ll need to succeed in the role:
“We obsess over learning. We don’t have to be the smartest; we have to learn the fastest.”
You’ll need to stay current on regulatory updates, PV systems, and workflows to adapt quickly in a constantly evolving safety landscape. Your proactive learning mindset will be essential for continuous improvement and inspection readiness.“We digitize everywhere possible using the power of code to maximize our impact on patients.”
This role offers opportunities to leverage automation, digital tools, and explore Generative AI applications to enhance case management efficiency and data quality. Embracing this mindset will help you thrive in a tech-forward pharmacovigilance environment.
Here’s What You’ll Bring to the Table:
University degree in Pharmacy/Medicine or other relevant life sciences discipline (Dentistry, Experimental Medicine, Microbiology, Veterinary, Biotechnology, Physiotherapy, Medical Biology or similar)
Minimum 3 years of experience in drug safety/pharmacovigilance case processing
Solid knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada
Argus safety database and other platforms MS Office suite, Excel, Powerpoint, SmartSheet, Visio
Effective time management skills
Excellent communication skills (verbal and writing); results oriented and strong attention to detail
Fluency in English required
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments
- Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at [email protected] .
